Events

Recall of Device Recall Abbott Commander Flexible Pipetting Center (FPC) Operations Manual

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Laboratories HPD/ADD/GPRD.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    27898
  • Event Risk Class
    Class 3
  • Event Number
    Z-0297-04
  • Event Initiated Date
    2003-12-02
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-07-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30711
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
    unknown device name - Product Code JQW--
  • Reason
    The operations manual has the wrong farenheit temperature range listed (102-122) instead of (104-122) for the preparation of the terg-a-zyme solution used to clean pipettes of the abbott commander flexible pipetting center.
  • Action
    Abbott sent 'Important Product Information' letters dated 12/2/03 to the end user accounts, advising them of the error in conversion of the Celsius temperature range to Farenheit in the first step in preparing the Terg-A-Zyme cleaning solution. The letter listed the entire corrected solution preparation procedure and advised the accounts to retain the letter with the Abbott FPC Operations Manual for future reference.

Device

Device Recall Abbott Commander Flexible Pipetting Center (FPC) Operations Manual
  • Model / Serial
    all revision numbers, all versions
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and internationally through Abbott affiliates in Colombia, Brazil, Puerto Rico, Japan, Singapore, Hong Kong and Germany.
  • Product Description
    Abbott Commander Flexible Pipetting Center (FPC) Operations Manual, list 6A97-27; Abbott Laboratories, Abbott Park, IL 60064
  • Manufacturer
    Abbott Laboratories HPD/ADD/GPRD

Manufacturer

Abbott Laboratories HPD/ADD/GPRD
  • Manufacturer Address
    Abbott Laboratories HPD/ADD/GPRD, 100/200 Abbott Park Road, Abbott Park IL 60064
  • Source
    USFDA